Not provided
Not provided
Not provided
Not provided
Not provided
The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLX-PAD Treatment | Experimental | PLX-PAD 300 million cells (20 million/mL) administered via 15 IM injections (1 mL each). Single administration in addition to best standard medical care. |
|
| Control Group | No Intervention | Best standard medical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLX-PAD | Biological | PLX-PAD - allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of ventilator-free days | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 28 and 60 days | |
| Duration of mechanical ventilation | 28 and 60 days |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite Campus Virchow | Berlin | 10117 | Germany | |||
| Campus Benjamin Franklin - CBF Charité - Universitätsmedizin |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Berlin |
| 12203 |
| Germany |
| University of hospital Bonn | Bonn | 53127 | Germany |
| Hospital Cologne-Merheim | Cologne | 51109 | Germany |
| Emek Medical Center | Afula | 1834111 | Israel |
| Bnai Zion Medical Center | Haifa | 31048 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Galilee Medical Center | Nahariya | 22100 | Israel |
| Baruch Padeh Medical Center, Poriya | Tiberias | 15208 | Israel |